Injection method for locating vessel lumen

ABSTRACT

A method of locating a vessel lumen to enable placement of a vascular hole closure device comprising the steps of providing a syringe containing a fluid therein, connecting the syringe to an elongated instrument, exerting a force on the syringe plunger as it is inserted through the tissue towards the vessel wall, and detecting movement of the syringe to eject the fluid to determine entry of the elongated instrument into the vessel lumen.

This application is a divisional of U.S. patent application Ser. No.10/163,142, filed Jun. 5, 2002, which claims priority from provisionalpatent application Ser. No. 60/355,526, filed Feb. 6, 2002 and is acontinuation-in-part of U.S. patent application Ser. No. 09/659,648,filed Sep. 12, 2000 now abandoned which claims priority from provisionalpatent application Ser. No. 60/153,736, filed Sep. 13, 1999.

BACKGROUND

1. Technical Field

This application relates to a vascular device and more particularly to adevice for closing openings in vessel walls.

2. Background of Related Art

During certain types of vascular surgery, catheters are inserted throughan incision in the skin and underlying tissue to access the femoralartery in the patient's leg. The catheter is then inserted through theaccess opening made in the wall of the femoral artery and guided throughthe artery to the desired site to perform surgical procedures such asangioplasty or plaque removal. After the surgical procedure is completedand the catheter is removed from the patient, the access hole must beclosed. This is quite difficult not only because of the high blood flowfrom the artery, but also because there are many layers of tissue thatmust be penetrated to reach the femoral artery.

Several approaches to date have been used to close femoral access holes.In one approach, manual compression by hand over the puncture site isaugmented by a sandbag or weight until the blood coagulates. With thisapproach, it can take up to six hours for the vessel hole to close andfor the patient to be able to ambulate. This inefficiency increases thesurgical procedure time as well as the overall cost of the proceduresince the hospital staff must physically maintain pressure and thepatient's discharge is delayed because of the inability to ambulate.

In another approach to close the vessel puncture site, a clamp isattached to the operating table and the patient's leg. The clamp appliespressure to the vessel opening. The patient, however, must still bemonitored to ensure the blood is coagulating, requiring additional timeof the hospital staff and increasing the cost of the procedure.

To avoid the foregoing disadvantages of manual pressure approaches,suturing devices have been developed. One such suturing device, referredto as “the Closer” and sold by Perclose, advances needles adjacent thevessel wall opening and pulls suture material outwardly through the walladjacent the opening. The surgeon then ties a knot in the suture,closing the opening. One difficulty with the procedure involves thenumber of steps required by the surgeon to deploy the needles, capturethe suture, withdraw the suture, and tie the knot and secure the suture.Moreover, the surgeon cannot easily visualize the suture because of thedepth of the femoral artery (relative to the skin) and essentially tiesthe suture knot blindly or blindly slips a pre-tied knot into position.Additionally, the ability to tie the knot varies among surgeons;therefore success and accuracy of the hole closure can be dependent onthe skill of the surgeon. Yet another disadvantage of this suturinginstrument is that the vessel opening is widened for insertion of theinstrument, thus creating a bigger opening to close in the case offailure to deliver the closure system. It is also difficult to pass theneedle through calcified vessels.

U.S. Pat. No. 4,744,364 discloses another approach for sealing a vesselpuncture in the form of a device having an expandable closure memberwith a filament for pulling it against the vessel wall. The closuremember is held in place by a strip of tape placed on the skin to holdthe filament in place. However, the closure device is still subject tomovement which can cause leakage through the puncture. Additionally, ifthe suture becomes loose, the closure member is not retained and canflow downstream in the vessel. Moreover, since the suture extendsthrough the skin, a potential pathway for infection is created. Theclosure device in U.S. Pat. No. 5,545,178 includes a resorbable collagenfoam plug located within the puncture tract. However, since coagulationtypically takes up to twenty minutes and blood can leak in between theplug and tissue tract, manual pressure must be applied to the puncturefor a period of time, until the collagen plug expands within the tract.

It would therefore be advantageous to provide a device which would morequickly and effectively close openings (punctures) in vessel walls. Suchdevice would advantageously avoid the aforementioned time and expense ofapplying manual pressure to the opening, simplify the steps required toclose the opening, avoid widening of the opening, and more effectivelyretain the closure device in the vessel.

SUMMARY

The present invention overcomes the disadvantages and deficiencies ofthe prior art. The present invention provides a device for closing anaperture in a vessel wall comprising an elongated member positionableinside the vessel against an internal opening of the aperture and havinga dimension at least substantially equal to a dimension of the internalopening to prevent egress of fluid through the aperture, and at leasttwo curved legs positionable outside the vessel to help retain theelongated member in position.

The at least two curved legs are preferably wires composed of shapememory material. In one embodiment, a connecting member in the form of aflexible wire couples the curved legs to the elongated member.Preferably, a retaining member in the form of a collar secures thecurved legs therein.

In one embodiment, a tube having a series of slots for flexibility andan opening to receive the curved legs is connected to the elongatedmember for moving the elongated member toward the internal opening ofthe aperture.

In one embodiment, the elongated member has a lengthwise dimensionexceeding the widthwise dimension, and the widthwise dimension has anenlarged dimension at a region between first and second ends of theelongated member. In another embodiment, the elongated member has anenlarged width region at one end and an adjacent reduced width region atanother end. The elongated member, in one embodiment, is composed of aresorbable material. In a preferred embodiment, the elongated member isbiased to a position transverse to an axis extending from the externalopening to the internal opening.

The present invention also provides an apparatus for closing an aperturein a vessel comprising a closure device having an aperture coveringmember and at least one leg connected to the covering member wherein thecovering member and the at least one leg are movable between aninsertion position and a deployed position. In the insertion position,the covering member is substantially parallel to a longitudinal axis ofthe aperture and in the deployed position the covering member issubstantially perpendicular to the longitudinal axis of the aperture ona first side of the aperture. In the insertion position, the at leastone leg is in a substantially straightened position and in the deployedposition has a curved configuration to grasp tissue on a second side ofthe aperture.

In one embodiment, a plurality of curved legs are provided, composed ofwire elements which extend downwardly toward the vessel and inwardlytoward the aperture in the deployed position. The aperture coveringmember preferably has an enlarged width portion. In one embodiment, theaperture covering member is composed of a resorbable material.

The present invention also provides an apparatus for closing an aperturein a vessel comprising a patching member and a retaining member, whereinthe patching member is positioned inside the vessel in contact along aportion of the inner vessel wall and has a dimension at leastsubstantially equal to a dimension of the aperture to cover the apertureand prevent blood flow through the aperture. The retaining member ispositioned outside the vessel wall and includes at least one grippingelement which extends inwardly toward the aperture and directs tissuetowards the aperture.

A system for closing an aperture in a vessel wall is also providedcomprising a closure device and a delivery instrument for delivering theclosure device. The closure device has an aperture covering member and aretaining member, wherein the aperture covering member is positionableinside the vessel and dimensioned to cover an internal side of theaperture and the retaining member has a plurality of curved legsengaging tissue outside the vessel. The delivery instrument has aholding member releasably engagable with the closure device to positionand to release the closure device.

In one embodiment, the holding member comprises a slotted tubereleasably positioned over a portion of the closure device. The slottedtube can be positioned over a collar which retains the curved legs.

The present invention further provides a system for closing an aperturein a vessel wall comprising:

-   -   a) a closure device having an aperture covering member and a        retaining member, the aperture covering member positionable        inside the vessel and dimensioned to cover an internal side of        the aperture in the vessel wall, and the retaining member having        a plurality of curved legs engaging tissue outside the vessel;        and    -   b) a delivery instrument for delivering the closure device, the        delivery instrument having an outer tube and a pusher slidably        disposed within the outer tube, wherein the pusher engages the        retaining member to advance the covering member from the outer        tube.

The delivery instrument is preferably insertable through an introducersheath, and snap fitted thereon, such that a distal end of the outertube remains proximal of a distal end of the introducer sheath. Thepusher in one embodiment has a plurality of longitudinal slots toreceive the curved legs when in a straightened position within thedelivery instrument. A retention mechanism is preferably provided forretaining the pusher in an initial position and in an advanced positionto deploy the retaining member. In one embodiment, a portion of theouter tube has a diameter less than a lengthwise dimension of theaperture covering member so that the portion of the outer tube bulgesoutwardly when the covering member is positioned therein.

The present invention also provides a method for closing an aperture ina vessel wall comprising:

providing a closure device having an elongated member and a plurality ofretention legs;

deploying the elongated member in the vessel to cover a first internalside of the aperture; and

deploying the retention legs outside the vessel wall wherein the legsassume a curved configuration to grasp tissue on a second external sideof the aperture.

The step of deploying the elongated member preferably comprises the stepof actuating a pusher to advance the elongated member distally. Themethod may further comprise the steps of placing an introducer sheaththrough the aperture into the vessel and connecting a deliveryinstrument containing the closure device to the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of the closure deviceof the present invention showing the clip legs in their memorizedposition;

FIG. 2 is a bottom view of the closure device of FIG. 1;

FIGS. 3-5 are front views of the closure device of FIG. 1 (the suturenot shown for clarity) showing movement of the clip legs to theirmemorized position wherein:

-   -   FIG. 3 shows the clip legs in a partially deflected (curved)        position;    -   FIG. 4 shows the clip legs in a further deflected position; and    -   FIG. 5 shows the clip legs in their memorized position;

FIG. 6 is a side view illustrating the closure device of FIG. 1partially deployed from the introducer sheath wherein the elongatedmember is retained in a longitudinal position;

FIG. 7 is a view similar to FIG. 6 except showing the closure devicefurther deployed from the introducer sheath to enable the elongatedmember to rotate to its transverse position;

FIG. 8 is a transverse cross-sectional view showing the positioning ofthe connecting wire and the clip legs within the collar of the closuredevice;

FIG. 9A is a perspective view of a second embodiment of the closuredevice of the present invention having an alternately configuredelongated member;

FIG. 9B is a perspective view of a third embodiment of the closuredevice of the present invention having a paddle shaped elongated member;

FIG. 9C is an exploded view of the closure device of FIG. 9B;

FIG. 9D is a side view of the closure device of FIG. 9B;

FIG. 9E is a transverse cross-sectional view showing the positioning ofthe connecting wire and clip legs of FIG. 9B within the collar of theclosure device;

FIG. 10A is a perspective view of a Fourth embodiment of the closuredevice of the present invention having clip legs formed of independentflat wire sections;

FIG. 10B is a perspective view of a fifth embodiment of the closuredevice of the present invention having clip legs integrally formed fromrectangular tubing;

FIG. 11A is a perspective view of a sixth embodiment of the closuredevice of the present invention having a connecting wire extendingthrough an eyelet of the elongated member;

FIG. 11B is a perspective view of a seventh embodiment of the closuredevice of the present invention having a connecting wire insert moldedin the elongated member;

FIG. 11C is a perspective view of an eighth embodiment of the closuredevice of the present invention having flattened clip legs with aretaining mechanism engagable with the collar;

FIG. 11D is a schematic representation of an elongated member withvarying regions of resorbability;

FIGS. 12A-12E are perspective views, with a portion of the vessel cutaway, illustrating a first method of delivery of the closure device ofFIG. 1 wherein:

-   -   FIG. 12A shows the dilator and sheath inserted over the        guidewire into the target vessel;    -   FIG. 12B shows the delivery instrument positioned within the        introducer sheath inserted through the skin opening and through        the vessel wall aperture into the interior of the vessel;    -   FIG. 12C illustrates the elongated member of the closure device        advanced beyond the distal end of the introducer sheath into the        vessel lumen;    -   FIG. 12D illustrates the closure device pulled proximally so the        elongated member abuts the internal wall of the vessel to cover        the internal opening of the aperture; and    -   FIG. 12E illustrates the introducer sheath and delivery        instrument being fully withdrawn to fully deploy the closure        device so the clip legs move toward their memorized position to        engage the tissue;    -   FIG. 12F is a side view showing the introducer sheath extending        through the internal and external openings of the vessel wall        aperture;

FIGS. 13A-13E are perspective views, with a portion of the vessel cutaway, illustrating an alternate method of delivery of the closure deviceof FIG. 1 wherein:

-   -   FIG. 13A shows the dilator and sheath being inserted over the        guidewire into the target vessel;    -   FIG. 13B shows the delivery instrument positioned within the        introducer sheath inserted through the skin opening and through        the vessel wall aperture into the interior of the vessel to a        position where it is desirable to deploy the elongated member;    -   FIG. 13C illustrates the introducer sheath withdrawn proximally        in a slot in the delivery instrument to release the elongated        member of the closure device into the vessel;    -   FIG. 13D illustrates the closure device pulled proximally so the        elongated member abuts the internal wall of the vessel to cover        the internal opening of the aperture; and    -   FIG. 13E illustrates the introducer sheath and delivery        instrument being fully withdrawn to fully deploy the closure        device so the clip legs move toward their memorized position to        engage the tissue;

FIG. 14 is a perspective view similar to FIGS. 12D and 13D showing theclosure device partially deployed so that the elongated member is in itstransverse position against the internal wall of the vessel;

FIG. 15 is an enlarged perspective view of the region of the closuredevice outlined in FIG. 14;

FIG. 16A is a perspective view of a ninth embodiment of the closuredevice of the present invention placed by a delivery instrument having aslotted tube overlying the collar;

FIG. 16B is a perspective view of the slotted tube of FIG. 16A;

FIG. 16C is a transverse cross-sectional view taken through the collarof FIG. 16A;

FIG. 16D is a perspective view of an alternate delivery instrument ofthe present invention for placement of the closure device, theinstrument having a pair of jaws engaging the collar (the clip legsremoved for clarity);

FIG. 17A is a front view of a tenth embodiment of the closure device ofthe present invention having a mushroom shaped aperture covering member;

FIG. 17B is a side view of the closure device of FIG. 17A;

FIG. 18 is a side view of another alternate embodiment of the deliveryinstrument for the closure device having a projecting tip for pivotingthe elongated member;

FIG. 19 is a side view of the closure device of FIG. 15 with thedelivery instrument of FIG. 18;

FIG. 20 is a side view of an eleventh embodiment of the closure deviceof the present invention having a wire offset with respect to theelongated member for biasing the elongated member to the transverseposition;

FIG. 21 is a perspective view of yet another alternate embodiment of thedelivery instrument for the closure device of the present inventionhaving a pair of jaws for grasping and releasing the closure device;

FIG. 22 is an enlarged view of the region outlined in FIG. 21 showingthe jaws grasping the closure device;

FIG. 23A is a perspective view of an insertion tube configured forinsertion into the introducer sheath;

FIG. 23B is a longitudinal cross-sectional view of the insertion tubepositioned within the introducer sheath;

FIG. 24A is a side view of the delivery instrument being inserted intothe introducer sheath;

FIG. 24B is a view taken along lines B—B of FIG. 24A showing the sheathand insertion tube in cross-section and the closure device positionedtherein;

FIG. 25A is a side view similar to FIG. 24A except showing the deliveryinstrument inserted further into the introducer sheath;

FIG. 25B is a view taken along lines B—B of FIG. 25A showing theintroducer sheath in cross section and the closure device positionedtherein deflecting the sheath;

FIG. 26A is a side view similar to FIG. 24A except showing the deliveryinstrument fully inserted into the introducer sheath;

FIG. 26B is a cross-sectional view taken along lines B—B of FIG. 26Ashowing the closure device positioned therein and deflecting the sheath;

FIG. 26C is a cross-sectional view of the distal end of the introducersheath of FIG. 26A;

FIG. 26D is a cross-sectional view similar to FIG. 26B except showingthe closure device of FIG. 11B positioned in the introducer sheath;

FIG. 27A is a perspective view of a twelfth embodiment of the closuredevice of the present invention having a spiral tube;

FIG. 27B is a perspective view of the closure device of FIG. 27Apositioned to close the aperture in the vessel wall;

FIG. 28A is a side view of a thirteenth embodiment of the closure devicehaving a single clip leg shown in a deflected position;

FIG. 28B is a side view of the clip of FIG. 28A showing the range ofmovement of the clip leg;

FIG. 29A is a side view of a fourteenth embodiment of the closure devicehaving a single clip leg shown in a partially deflected position;

FIG. 29B is a side view of the closure device of FIG. 29A showing theclip leg in a fully deflected position;

FIG. 30 is a side view of the closure device of FIG. 29A showing theclip leg in the straightened position within the delivery instrument;

FIG. 31 is a perspective view of another alternate embodiment of thedelivery instrument of the present invention for placement of theclosure device showing the instrument positioned in an introducersheath, the plunger in the retracted position, and the syringe connectedto the extension assembly;

FIG. 32 is a cross-sectional view of the proximal end of the deliveryinstrument of FIG. 31 showing the plunger in the retracted position;

FIG. 33 is a transverse cross-sectional view taken along lines C—C ofthe delivery instrument of FIG. 31 (with the introducer sheath removedfor clarity);

FIG. 34 is a longitudinal sectional view showing a portion of thedelivery instrument of FIG. 31 positioned in an introducer sheath;

FIG. 35 is a side view illustrating the distal end of the deliveryinstrument and the closure device in the introducer sheath; and

FIG. 36 is a side view showing the elongated member advanced from thedelivery instrument and introducer sheath by the pusher.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, FIG. 1is a perspective view of first embodiment of the vascular hole(aperture) closure device of the present invention. The device isintended to close an aperture in the vessel wall, typically formed afterremoval of a catheter previously inserted through the vessel wall intothe vessel lumen for performing angioplasty or other interventionalprocedures. The aperture extends through the patient's skin andunderlying tissue, through the external wall of the vessel, through thewall of the vessel, and through the internal wall of the vessel tocommunicate with the internal lumen of the vessel. The closure devicesof the present invention have a covering member or patch positionedwithin the vessel pressing against the internal wall of the vessel toblock blood flow and a clip positioned external of the vessel wall toretain the covering member. The clip pulls the covering member upwardlytowards the aperture.

Turning first to FIGS. 1-5, a first embodiment of the closure device ofthe present invention is illustrated. Hole (aperture) closure device 10has an elongated member 12 and a clip 14 having four legs, preferably inthe form of wires, 30 a, 30 b, 30 c, and 30 d retained within a collar38. The elongated member 12 is dimensioned and configured forpositioning inside the vessel on the internal side of the aperture; thewires 30 a-30 d are configured to be positioned outside the vessel walladjacent the external side of the aperture.

Elongated member 12 is retained in a longitudinal position for deliveryto the vessel, and then pivots to a transverse position within thevessel lumen. This movement is illustrated in FIGS. 6 and 7 whereinelongated member 12 is partially deployed from the introducer sheath300, but still retained in a longitudinal position by engagement of thewall at distal end 303 (FIG. 6) with end region 18. When fully deployedfrom the introducer sheath 300, end region 18 of elongated member 12 isalso released so it can pivot to the transverse position of FIG. 7 whereit's substantially perpendicular to an axis extending through theaperture. Note that preferably the center of collar 38 is slightlyoffset from the eyelet 24, enabling the elongated member 12 to pivotslightly when deployed; the vessel wall can then further pivot theelongated member to a transverse position as it is pulled back againstthe wall. This movement is described in more detail below in conjunctionwith the discussion of the method of insertion of closure device 10. Thelegs 30 a-30 e of the clip 14 are retained in a substantiallystraightened position for delivery and when released moved to a curvedconfiguration. This is also discussed in detail below.

The elongated member 12 functions to cover (patch) the internal openingin the vessel wall to prevent the egress of blood. As illustrated inFIGS. 1 and 2, the elongated (covering) member has an enlarged region 20between the first and second end regions 16, 18. The longitudinal axisdefines a lengthwise dimension L and transverse axes define widthwisedimensions. The widthwise dimension w1 at the ends 16 and 18 of theelongated member 12 are preferably substantially equal and preferablyrange from about 0.025 inches to about 0.035 inches. At the enlargedregion 20, the widthwise dimension progressively increases, so itsmaximum width w2 preferably ranges from about 0.090 inches to about0.125 inches. This central enlarged region 20 of elongated member 12provides a larger area to patch (cover) the internal opening in thevessel. The width w2 preferably is at least substantially equal to thedimension of the internal opening to effectively cover the opening.Other dimensions are also contemplated.

It should be appreciated that the elongated member could be providedwithout an enlarged region as long as it has sufficient area to coverthe opening (aperture). This is illustrated by way of example in FIG.9A, wherein closure device 50 has an elongated member 60 which issubstantially uniform in width throughout its length. In thisembodiment, connecting wire 56 abuts projecting surface 62 of elongatedmember 60 to tip (pivot) the elongated member 60. In all other respects,closure device 50 is identical to device 10, e.g. four legs 52 a, 52 b,52 c and 52 d retained within a collar 59 and connected to elongatedmember 60 by connecting wire 56 extending through the opening inprojecting surface 62.

The elongated member could also be configured asymmetrically so that theenlarged region is off centered to accommodate widening of the apertureas the member is pulled at an angle. The elongated member can also beconfigured in a paddle shape with a narrowed region adjacent a widerregion as discussed below in conjunction with FIGS. 9B-9E.

The elongated member can be composed of materials such as polycarbonateor polyurethane, or alternatively can be composed of resorbablematerials such as glycolide/lactide polymers which after a period oftime resorbs in the body, leaving only the clip portion external of thevessel lumen. If composed of resorbable material, the elongated membercould optionally have regions of varying resorbability. One example isshown in FIG. 11D, where region R1 would be the last to resorb, regionR2 would resorb at a slower rate, and Region R3 would be the first toresorb. One of more of these regions, e.g. R1 and R2, could optionallynot be resorbable.

With continued reference to the closure device 10 of FIGS. 1-5, theelongated member 12 has an opening or eyelet 24 formed in projectingsurface 22. Opening 24 receives a connecting wire 40 to couple the clip14 to the elongated member 12.

The clip legs 30 a-30 d of clip 14 each have a first portion whichextends through collar 38, terminating at ends 33 a-33 d, respectively,and a second end 32 a-32 d, respectively, which is configured to engagetissue. In FIG. 1, the ends 32 a-32 d are non-penetrating blunt tips.However, it is also contemplated that sharpened or tissue penetratingtips could alternatively be provided. The clip legs 30 a-30 d areretained in the collar 38 by laser welding, glue, or other securingmeans. Alternatively, the clip legs can be welded or otherwise attachedto each other (and the connecting wire) without the need for a collar.

Also fixed within collar 38, by any suitable means, e.g. laser weldingor glue, is connecting wire 40 which loops at region 42 through opening24. The two ends of the connecting wire are designated by referencenumeral 44. (Only one end is shown). FIG. 8 illustrates a transversecross-sectional view taken through collar 38 to illustrate thepositioning of the clip legs 30 a-30 d and connecting wire 40 within thecollar 38. Suture 45 also extends through eyelet 24 and functions toposition the elongated member 12 as described in detail below.

Clip legs 30 a, 30 b, 30 c, and 30 d are preferably composed of fourdiscrete wire elements composed of shape memory material, such asNitinol (nickel titanium alloy) with a memorized position of that shownin FIG. 5. In use, the clip legs 30 a-30 d are retained in the deliveryinstrument in a substantially straightened position, and when released,are warmed by body temperature to curve inwardly as shown in FIGS. 3 and4. The extent to which the clip legs can return to their memorizedposition will depend on the thickness and resistance of the tissue. Oncecurved inwardly, the curved clip legs 30 a-30 d grasp the tissue toretain the closure device 10 within the tissue. As the legs 30 a-30 dcurve inwardly, they apply a proximal pulling force on the elongatedmember 12 to pull it slightly upwardly (proximally) against the vesselwall. The legs may gather and force tissue on the external side of thevessel wall toward the opening.

FIG. 10A illustrates an alternate embodiment of the closure device ofthe present invention, designated by reference numeral 70. Closuredevice 70 is similar to closure device 10 except for the shape of theclip legs 78 (only two of which are shown) and the collar 75. Clip legs78 (preferably four are provided) are made of wire having a rectangularcross-sectional shape. The clip legs 78, as shown, are formed into anelongated U-shape. Also, instead of the cylindrical collar 38 of closuredevice 10, a rectangular shaped collar 75 is provided. In all otherrespects, e.g. elongated covering member 72, connecting wire 73, etc.closure device 70 is identical to closure device 10.

In the embodiment of FIG. 10B, the clip legs 84 a-84 d of closure device80 are initially formed from rectangular (or square) tubing. As shown,tubing 86 is split, preferably by laser cutting to form the four curvedlegs 84 a-84 d which in their closed position form a C-shapeconfiguration. Elongated covering member 85 is identical to elongatedmember 12 of closure device 10 with an enlarged width region 85 forcovering (patching) the internal side of the opening. A connecting wire83 connects the clip portion to the elongated member via eyelet 88. Plug87 is slip fit over connecting wire 83 and has one or more tabs 89 snapfit through window 86 a in tubing 86 to connect the elongated member 82to the tubing 86.

It should be appreciated that the other embodiments disclosed hereincould also have retaining tabs for attachment to the collar portion.

FIG. 11A is a perspective view of another alternate embodiment of theclosure device. In this embodiment, closure device 90 has four legs 94(only two of which are shown) as in the embodiment of FIG. 1. Instead ofa suture extending through the eyelet 24 as shown in FIGS. 1 and 14,suture 97 is connected to the loop 95 of connecting wire 96. That is,connecting wire 96 is looped through eyelet 93 of elongated member 92 atone end and receives a suture loop 95 at the opposite end. In thismanner, as the suture is pulled proximally, the elongated member (andclip) are pulled proximally. Connecting wire 96 is preferably attachedwithin collar 98 by laser welding, gluing, or other suitable means.Connecting wire 96 can be utilized to bias the elongated member to atransverse position.

In the embodiment of FIG. 11B, the connecting wire 116 of closure device110 is embedded, e.g. insert molded, within the elongated member 112.This reduces the profile of the elongated member 112 since theprojecting surface (protrusion) as in the FIG. 11A embodiment iseliminated. Also, the connecting wire 116 is made of material, e.g.shape memory metal, which is designed to be in a substantiallystraightened position, or alternatively in an angled position such as 45degrees. This configuration biases the elongated member 112 to thetransverse position. Otherwise, device 110 is identical to device 90,e.g. legs 114 (only two are shown), suture 117 attached to connectingwire 116, etc.

FIGS. 9B-9E illustrate an alternate embodiment of the closure device,designated by reference numeral 140, having a flexible connecting wire146 attached to elongated covering member 142 by insert molding,mechanical connection or other suitable means. As shown, connecting wire146, optionally composed of shape memory material such as Nitinol, ispositioned off center of the connecting member 142 to bias it to thetransverse position and to facilitate movement of the connecting member142 to the longitudinal position for delivery to the vessel. Theproximal end of connecting wire 146 is attached by suitable means to thecollar 148. Four clip legs 144 as in the embodiment of FIG. 1 areprovided. The clip legs 144 can have hooked tips 145 as shown which arepositioned within and engage collar 148 to facilitate securementtherein.

The elongated covering member 142 is paddle shaped having an enlargedregion 142 a and a narrowed region 142 b, thereby reducing its profileso the overall amount of material left in the vessel after placement ofthe closure device 140 is reduced. Narrowed region 142 b can optionallyprogressively taper starting from the transition with the enlargedregion 142 a.

In a preferred manufacturing method, the collar 148, clip legs 144 andconnecting wire 146 are laser welded together. The connecting wire 146,with tag end 147 is subsequently connected to covering member 142 in theorientation shown. In this preferred attachment method, covering member142 has a longitudinal slot with interference bumps (not shown)dimensioned to receive the tag end 147 of connecting wire 142.Absorbable or non-absorbable glue could optionally be applied to enhancethe attachment of tag end 147 and to provide a seal.

FIG. 11C illustrates another alternate embodiment of the closure device,designated by reference numeral 130. Closure device 130 has clip legs134 a-134 d with planar surfaces formed from wire of rectangularcross-section and is preferably composed of shape memory metal. Aconnecting strap 136, or alternatively a connecting wire like wire 96 ofFIG. 11A, extends through eyelet 133 of elongated member 132. Suture 137is looped through strap 136 for pulling elongated member 132 against theinternal opening of the aperture. The clip legs 134 a-134 d are retainedwithin collar 138 by engagement of a respective tab 139 on each of thelegs extending through a respective window 135 on collar 138.

In the closure devices described herein, four discrete wire legs aredisclosed spaced approximately 90 degrees apart. However, it is alsocontemplated that fewer legs, e.g. two legs spaced approximately 180degrees apart or three legs spaced approximately 120 degrees apart, ormore than four legs can be provided to achieve the device retentionfunction. It should be appreciated that in a four clip version, toconserve space, i.e. minimize the size for positioning within thedelivery instrument and introducer sheath, the legs need not besymmetrically spaced with respect to one another, but preferably atleast the opposing legs would be about 180 degrees apart. (see e.g. FIG.16C).

FIGS. 28-30 illustrate an example of a single clip leg utilized toretain the elongated member and exert a proximal force on the tissue andelongated member. In FIGS. 28A, 28B, curved clip leg 702, when deployedfrom delivery instrument 703 curves inwardly as shown to grasp tissueand secure elongated member 704 against the internal vessel wall. InFIGS. 29 and 30, clip leg 740, directly connected to elongated member744, is retained in a substantially straightened position within thedelivery instrument 742 (FIG. 30), and when deployed curves arounditself, to form a spring-like element, as shown in FIG. 29B. This clipleg 740 coils to pull up on the elongated member 744 to retain it withinthe vessel.

Also, in each of the embodiments described herein, blunt tips orsharpened tips can be provided on the clip legs to perform theirgripping function. Although preferably composed of shape memorymaterial, the clip legs can alternatively be composed of stainlesssteel, resorbable material, or other materials.

Tuning now to the placement of the closure device of the presentinvention, FIGS. 12A-12E illustrate a first insertion method. The methodillustrated shows placement of closure device 10, however, it should beunderstood that the other closure devices described herein can beinserted in a similar manner.

As shown in FIG. 12A, a dilator 304 is inserted through introducersheath 300 and over a guidewire 302 into the vessel lumen. Note thesheath and dilator 304 extend through opening “a” in the skin, throughthe tissue tract to the vessel V, through external opening “b” in thevessel wall, through the aperture in the vessel wall “w”, and through aninternal opening “c” on the interior side of the vessel wall into thevessel lumen (see also FIG. 12F).

Next, the guidewire 302 and dilator 304 are withdrawn, and closureapplying (delivery) instrument 310 is inserted through the sheath 300into the vessel lumen as shown in FIG. 12B. The elongated member 12extends distally of the delivery instrument 310 and is retained in alongitudinal position by the walls of the introducer sheath 300; theclip legs are retained in a substantially straightened position in amartensitic state within the delivery instrument by the infusion of coldsaline.

The delivery instrument 310 is advanced through the introducer sheath300 and past the distal tip 303 so the elongated member 12 is outsidethe confines of the wall of the introducer sheath 300 and extends intothe vessel lumen sufficiently spaced from the internal opening in thevessel wall. This provides sufficient room for pivotal movement of theelongated member 12. As the elongated member 12 is released from theconfines of the wall, it is enabled to pivot toward a transverseposition as shown in FIG. 12C.

Next, the sheath 300 and delivery instrument 310 are pulled proximallyas a unit until the elongated member is seated against the internalopening c in the vessel wall w. (It is contemplated that the sheath 300and instrument 310 can optionally be fitted (locked) together so theycan be moved as a single unit.) Suture 45 extending through eyelet 24 ofelongated member 12 (see FIGS. 14 and 15), is attached to the deliveryinstrument 310 so that pulling the delivery instrument proximally pullsthe suture 45 and thus the elongated member 12 proximally. The elongatedmember 12 is pulled proximally to cover the opening in a patch-likemanner with the enlarged region 20 spanning the internal opening c toprevent egress of fluid. Note that the vessel wall further pivots theelongated member to the fully transverse position.

Once elongated member 12 is seated, the closure device is furtherejected from the delivery device 310 by distal movement of a pusher (notshown) against the clip legs, thereby forcing clip 14 from the deliveryinstrument 310 so the clip legs 30 a-30 d are warmed by body temperatureand move towards their memorized configuration. FIG. 12E illustrates theclosure device 10 in position with elongated member 12 abutting internalopening c on the internal side of the vessel V to cover (patch) theopening and the retention legs 30 a-30 d curving downwardly andpreferably slightly inwardly towards the tissue tract and aperture toengage the tissue and apply a proximal (upward) force on the elongatedmember 12. Tissue can also be forced by the curved clip legs 30 a-30 dtowards the aperture and tissue tract on the external side of the vesselwall. FIG. 12E also shows the introducer sheath 300 (and delivery device310) being withdrawn from the patient's body. The suture is withdrawnwith the delivery device 310.

Note that in one embodiment, the suture would be designed toautomatically rip when a sufficient load (exceeding a threshold amount)was placed on the suture, thereby separating the closure device from thedelivery instrument.

In an alternate insertion method, when the delivery instrument 310 isinserted through the introducer sheath 300, and the elongated member 12remains within the confines of the wall of the introducer sheath 300 theelongated member is ejected by a pusher rather than by advancement ofthe delivery instrument. That is, the pusher inside the deliveryinstrument would be actuated to advance the closure device so theelongated member 12 is moved distally, outside the confines of theintroducer sheath wall. In this deployed position of the elongatedmember 12, the clip legs 30 a-30 d still remain within the deliveryinstrument 310 and are not yet deployed. Optionally, the deliveryinstrument 310 can lock into the sheath 300 at a proximal end. Afterpulling back on the elongated member 12 to cover the internal opening ofthe vessel, the clip legs 30 a-30 d are deployed by moving the deliveryinstrument 300 proximally to expose the clip legs or by furtheractuating the pusher to advance the clip legs from the deliveryinstrument.

FIGS. 13A-13E illustrate an alternate method of insertion of the closuredevice 10 of the present invention. It should be understood that theother closure devices disclosed herein could also be delivered withdelivery instrument 320. The delivery method of FIGS. 13A-13E is thesame as the method of FIGS. 12A-12E except that instead of advancing theclosure device distally to free the elongated member for pivotalmovement, the introducer sheath 300 is retracted with respect todelivery instrument 320.

More specifically, in this method, the dilator (FIG. 13A) is introducedover the guide wire in the same manner as FIG. 12A. Note FIG. 13A showspartial introduction as the sheath would be advanced further into thevessel corresponding to the position of FIG. 13B. Note also, theintroducer sheath 300 is inserted into the vessel, but further into thevessel than in the method of FIG. 12, as shown in FIG. 13B. That is, thedistal tip 303 of the introducer sheath 300 is moved to the positionwhere it is desired to release the elongated member 12 into the vessel.Once in position, the introducer sheath 300 is retracted with respect tothe delivery instrument 320, with tubing connector 314 received in aslot 322 of delivery instrument 320. As the sheath 300 is retracted, theelongated member 312 is exposed as shown in FIG. 13C, thus enabling theelongated member 12 to pivot towards its transverse position as it is nolonger retained by the wall of the introducer sheath 300. The remainingsteps for pulling the elongated member 12 proximally and releasing theclip (illustrated in FIGS. 13D and 13E) are identical to the stepsdescribed above with respect to FIGS. 12D and 12E.

To enable movement between an expanded and collapsed configuration inthe delivery methods described herein, as noted above, clips legs 30a-30 d are preferably made of shape memory metal material, such asNitinol, a nickel titanium alloy. To facilitate passage of the clip legsthrough the lumen of the delivery instrument 320 and into the vessel,cold saline is injected into the delivery instrument 320 and around thelegs 30 a-30 d in their collapsed position within the deliveryinstrument 320. This shape memory material characteristically exhibitsrigidity in the austenitic state and more flexibility in the martensiticstate. The cold saline maintains the temperature dependent wires 30 a-30d in a relatively softer condition as they are in the martensitic statewithin the delivery instrument. This facilitates the exit of wires 30a-30 d from the delivery instrument 320 as frictional contact betweenthe wires 30 a-30 d and the inner surface of the instrument 320 wouldotherwise occur if the wires were maintained in a rigid, i.e.austenitic, condition. A stopcock 301 (see e.g. FIG. 24A) can controlthe flow of saline.

FIG. 23A illustrates an insertion tube 500 which can be utilized withthe introducer sheath 300 to enable a larger dimensioned deliveryinstrument and larger dimensioned elongated member 12 to be insertedthrough the introducer sheath 300. Insertion tube 500 has a head portion502 and an elongated tubular portion 504 extending from head portion502. A lumen 506 extends through the tube 500. As shown in FIG. 23B,insertion tube 500 is inserted through the valve 308 and into the lumen309 of introducer sheath 300. The tube 500 terminates proximal of thereduced lumen area 307 of sheath 300. Tube 500 steps down to a smallerinternal lumen diameter at region 509.

The lumen 506 of insertion tube 500 preferably has a diameter of about0.096 inches and can preferably step down to about 0.088 inches (region509). The lumen 309 of the introducer sheath 300 preferably has adiameter of about 0.125 inches and the reduced lumen area 307 preferablyhas a diameter D2 of about 0.087 inches, preferably stepped down to adiameter D3 of about 0.079 inches (see FIG. 26C). Preferably, the outerdiameter D1 of the introducer sheath 300 is about 0.105 inches and theouter diameter of the tubular portion 504 of the insertion tube 500 isabout 0.114 inches. The delivery instrument preferably has an outerdiameter of about 0.079 inches. The elongated member 12 preferably has alengthwise dimension of about 0.313 inches (8 mm). (Note that theforegoing dimensions are provided by way of example and other dimensionsare also contemplated.)

Due to the use of insertion tube 500, the elongated member 12 can bepositioned outside the delivery instrument 310 and fed into the lumen506 of tube 500 and lumens 309, 307, 305 of the sheath 300. As shown inFIGS. 24-26, when initially inserted, the closure device (collar 38,elongated member 12, etc.) fits within the confines of the sheath 300without deflecting the sheath wall (FIG. 24B). When the deliveryinstrument 310 is inserted further into the introducer sheath 500 asshown in FIG. 25A, the sheath wall is deflected as shown in FIG. 25B andis deformed as it is deflected beyond its elastic limit since theinternal diameter of the tip is smaller. Full insertion shown in FIG.26A further deflects (deforms) the wall as shown in FIG. 26B, beyond itselastic limit. Without the use of insertion tube 500, the elongatedmember 12 would have to be retained within the delivery instrument 310,which would require either a larger diameter delivery instrument 310 ora smaller (lengthwise) elongated member 12.

FIG. 26D illustrates the closure device of FIG. 11B positioned withinthe introducer sheath 300 to deflect the wall, corresponding to theposition of FIG. 26A.

FIGS. 16A-16C illustrate an alternate embodiment of the closure deviceof the present invention which utilizes a slotted tube to retract andrelease the closure device. Closure device 150 has an elongated member152 and clip legs 154 a-154 d identical to the elongated member 12 andclip legs 30 a-30 d of closure device 10 of FIG. 1. Closure device 150also has a collar 158 identical to the collar 38 of FIG. 1. A connectingwire 156, insert molded to elongated member 152 in the same manner asFIG. 11B, connects the clip portion of the device to the elongatedmember 152. The cross-sectional view of FIG. 16C illustrates how theclip legs 154 a-154 d and connecting wire 156 are seated within collar158 along the perimeter to facilitate manufacture.

A slotted tube 160 of the delivery instrument, having a series of slots162, e.g. four, to create a series of flexible fingers 164 is releasablyseated over collar 158 to hold the closure device. Due to thisinterference fit, when slotted tube 160, which is fixedly mounted to thedelivery instrument 161, is pulled proximally with the proximal movementof the delivery instrument, the collar 158, and thus the closure device150 is pulled proximally to seat the elongated member 152 against theinternal wall of the vessel to cover the internal opening of theaperture. When a sufficient load is placed on slotted tube 160, thefingers 164 flex outwardly and slide over the collar 158, therebyreleasing the closure device 150 from the slotted tube 160 of thedelivery instrument.

In an alternate embodiment (not shown), the release tube, instead ofbeing slotted, has a crimped or swaged tip which is positioned slightlydistally of the collar. This tip is flexible so that upon placement ofsufficient load on the tube, the tip flexes to ride over the collar torelease the closure device. Additionally, dimples could be provided onthe interior surface to help retain the tube over the collar, but whichwould enable release of the collar.

In the alternate embodiment of FIG. 16D, instead of a slotted tube, apair of jaws 181, 182 are fixed to the delivery instrument 180. Jaws181, 182 grasp collar 178 of closure device 170. Closure device 170 issubstantially identical to device 160 of FIG. 16A having an elongatedmember 172, a connecting wire 176, collar 178, and four clip legs 174(only the ends of two are shown for clarity). When a sufficient load isplaced on jaws 181,182, the jaws open and slide off collar 178, therebyreleasing the closure device 170 from the jaws of the deliveryinstrument.

In the embodiment of FIGS. 21 and 22, a pair of jaws 191 of deliveryinstrument 190 grasps one or more of the clip legs 30. The jaws 191,e.g. an alligator clamp, are spring biased to an open position and areretained by the wall of the introducer sheath 300 in the closed positionas shown in FIG. 22. When the delivery instrument is advanced withinintroducer sheath 300 past the distal tip 302, the jaws 191 move to theopen position to release the clip legs and closure device.

FIGS. 31-36 illustrate another alternate embodiment of a deliveryinstrument for placement of the closure device. Although described forplacement of closure device 140 of FIG. 9B, other closure devicesdescribed herein can be placed in a similar manner.

Turning first to FIGS. 31, delivery instrument 800 has a housing 801having winged grippers 802, a plunger 804 movable axially with respectto housing 801 to advance the closure device 140, and locking windows806 a, 806 b to secure the plunger 804 in a retracted and advancedposition, respectively. An elongated outer tube 805 extends from housing801 and is dimensioned to receive the closure device 140 therein.Connected to plunger 804 is a pusher 806 having four longitudinal slots807 (see FIGS. 33 and 36) to each receive a clip leg in the straightenedposition within the delivery instrument 800. The distal end of thepusher 806 abuts a region of the clip legs 144 proximal of the retainingcollar 148 as shown in FIG. 35.

When the plunger 804 is advanced, the pusher 806 is also moved distally,forcing the closure device 140 forward so that elongated member 142 isadvanced into the vessel and moves to its transverse position, helped bythe biasing force of offset connecting wire 146 described above. Notethat advancement of the plunger 804 moves flexible fingers 809 fromengagement in opposed locking windows 806 a to engagement in windows 806b to retain the plunger 804 and pusher 806 in the advanced position.Also note the angled surface 809 a of fingers 809 enable distal movementof the plunger 804 while straight surface 809 b prevents proximalmovement out of windows 806 a and 806 b (see FIG. 32).

The delivery instrument 800 is inserted into the vessel through anintroducer sheath, designated by reference numeral 900 in FIGS. 31 and35. The introducer sheath 900 has a hub 906 with a proximal opening 902to receive either a conventional dilator or the delivery instrument 800.Sheath tube 907 extends from hub 906 and has an opening 904 in the sidewall at the distal end. The distal end is tapered at region 909 toprovide a seal with the dilator. The proximal end of the sheath tube 907is flared at region 912 to enable a smooth transition for the outer tube805 of the delivery instrument 800 when it is inserted through theintroducer sheath 900 because with the closure device 140 in place, theouter tube 805 bulges outwardly. A strain relief 910 surrounds a portionof the sheath tube 907.

The hub 906 of sheath 900 has a 45 degree sidearm 913 having tubing 915,strain relief 914 and a male luer 916 for mounting extension assembly920. A conventional clamp 918 is placed on tubing 915. The distal end ofextension assembly 920 is screwed onto male luer 916 and the proximalend of extension assembly has a mounting assembly 922 with a screwthread for mounting a syringe which is described below.

Hub 906 further includes a valve assembly at the proximal end having aspacer ring 930, a cylindrical valve element 932 having a slitarrangement, and a sheath cap 934. The sheath cap 934 has an opening 936dimensioned to receive and mount by a snap fit arrangement a dilator(not shown) and the delivery instrument 800. A distal sheath cap 938 ismounted to the distal end of the hub 906. A collar 810 mounted inhousing 801 of the delivery instrument 800 and has a snap in tip 812fitted within the opening 936 in the sheath cap 934.

Placement of the closure device 140 using delivery instrument 800 willnow be described. First, to position the introducer sheath 900 in thevessel, a syringe 950, filled with fluid such as saline, is threadedonto proximal threads of extension assembly 920. The introducer sheath900, with a conventional dilator (not shown) snapped into sheath cap934, is inserted through the tissue tract over a guidewire toward thevessel wall, with the user attempting to depress the syringe plunger952. While the sheath 900 is still within the tissue tract, very littlesaline can be ejected from the syringe 950 through side opening 904.Thus there is little movement of the plunger 952. However, once theintroducer sheath 900 is advanced through the tissue tract and throughthe vessel wall into the vessel lumen, saline can freely flow outthrough side opening 904 (after flowing in the gap between the dilatorand the internal wall of the sheath 900), thus enabling more rapiddepression of the plunger 952. This provides a visual and tactile feelthat the introducer sheath 900 is desirably positioned within thevessel, thus ensuring that the closure device, when inserted through thesheath 900 via delivery instrument 800, will be inserted into the vessellumen.

Once the introducer sheath 900 is in place in the vessel, the dilator isremoved. The syringe 950 is either filled with cool saline or isdetached from the extension assembly 920 and another syringe with coolsaline is attached to threads 922. This cool saline is applied to theclosure device 140 during delivery to maintain the legs 144 andconnecting wire 146 in a cooled martensitic state as described abovewith respect to other embodiments.

After removal of the dilator, the delivery instrument 800 is ready forinsertion through the introducer sheath 900. The closure device 140 ispositioned in the delivery instrument 800 as shown in FIG. 35, with theclip legs 142 contained in longitudinal slots of the pusher 806. Theelongated member 142 is contained within the confines of the outer tube805. When inserted through and snapped into the introducer sheath 900,the outer tube 805 remains proximal of the distal tip of the introducersheath 900 as shown. Next, the plunger 804 is depressed to move thepusher 806 distally (until fingers 809 are positioned in windows 806 b)to advance the closure device 140 so the elongated member 142 is movedbeyond the confines of the outer tube 805 and beyond the distal tip ofthe introducer sheath 900. Once outside the confines of tube 805 andsheath 900, the elongated member 142 pivots to a transverse position asshown in FIG. 36.

The sheath 900 and delivery instrument 800 are then pulled proximally,pulling the elongated member 142 against the vessel wall. Once inabutment with the vessel wall, it applies a counterforce against theproximal movement of the sheath 900 and delivery instrument 800.Consequently, subsequent proximal movement of the sheath 900 andinstrument 800 will release the clip legs 144 from the confines of thesheath 900 and instrument 800, where the clip legs 144 will return totheir curved memorized temperature as they are warmed by bodytemperature. The sheath 900 and delivery instrument 800 are then removedfrom the body.

FIGS. 18-20 illustrate alternate embodiments of the delivery instrumentwhich facilitate repositioning of the elongated member within thevessel. That is, in these embodiments, the delivery (closure applying)instrument has a projecting distal tip with an abutment surfaceconfigured to engage one of the sides of the elongated member. Pressingof the abutment surface against the top surface of the elongated memberforces the elongated member to pivot back to a longitudinal position forwithdrawal from the vessel if desired. This more easily allowsrepositioning within the body prior to deployment of the clip.

More specifically, in FIG. 18, protruding tip 402 of instrument 400abuts upper surface 99 of elongated member 92. This figure shows use ofthe closure device 90 of FIG. 11A with the instrument 300. In FIG. 19,closure device 10′ is similar to closure device 10′ of FIG. 1 (and FIG.15), except for the separate opening for connecting wire 42′. Elongatedmember 12′ is pivotable back to the position shown in phantom by theprojecting tip 412 of instrument 410.

In FIG. 20, the elongated member 102 is biased to a transverse positionby the offset suture 104 of closure device 100. It can be pivoted by theprojecting tip of the instrument.

FIGS. 17A and 17B show a variation of the elongated member. Closuredevice 120 has a mushroom shaped saddle 121 which functions to abut theinternal wall of the vessel to cover the internal opening of the vesselaperture. The saddle 121 has a circular periphery with two opposingsides 125 curving downwardly. Clip legs 122 a, 122 b, 122 c, and 122 dextending from stem 124 function in the same manner as the clip legsdescribed above. Clip legs 122 a-122 d are shown with penetrating tips124 a-124 d, respectively, but non-penetrating tips can also beprovided. This closure device 210 is described in more detail incommonly assigned patent application Ser. No. 09/659,648, filed Sep. 12,2000, the entire contents of which are incorporated herein by reference.

FIGS. 27 and 28 illustrate an alternative embodiment of the closuremember of the present invention utilizing a different approach toconnecting the clip legs to the elongated member. This version differsfrom the foregoing embodiments as it eliminates a component to simplifymanufacture and simplify the device as a single element can be utilizedto both attach the portions of the closure member as well as to bias theelongated member. More specifically, closure device 600 has four legs602, similar to legs 30 of the embodiment of FIG. 1 in that they have amemorized curved configuration. A tube 604 is preferably welded toelongated member 603, but can be insert molded or attached by othermeans. Tube 604 is spiral cut to provide flexibility and allow bendingof the tube. Extending within the proximal end 606 of the tube 604 areclip legs 602, which are welded through the tube 604 at region 608.Other means of attachment could also be utilized. The proximal portion606 of tube 604 is not cut to provide rigidity at the region ofattachment to clip legs 602. The spiral tube thereby serves severalfunctions: connects the clip legs 602 to the elongated member 603 in aflexible manner, retains the clips legs, and biases the elongated member603 to a transverse position.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

1. A method of locating a vessel lumen to enable placement of a vascularhole closure device comprising the steps of: providing an elongatedinstrument; providing a syringe having a plunger and containing a fluidtherein; connecting the syringe to the elongated instrument; exerting aforce on the plunger as the elongated member is inserted through thetissue towards the vessel wall; and determining entry of the elongatedinstrument into the vessel lumen by detecting movement of the plunger toeject the fluid.
 2. The method of claim 1, wherein the step ofdetermining entry by detecting movement of the plunger comprises thestep of feeling the change in pressure of the plunger.
 3. The method ofclaim 1, wherein the step of connecting the syringe to the elongatedinstrument comprises the step of threading the syringe onto theelongated instrument.
 4. The method of claim 1, wherein the elongatedinstrument is an introducer sheath having a side opening formed in awall and the step of exerting a force on the plunger to eject the fluidejects the fluid through the side opening.
 5. The method of claim 4,further comprising providing a dilator within the introducer sheath andthe step of exerting a force on the plunger to eject the fluid ejectsthe fluid in the space between the dilator and sheath.
 6. A method forlocating a vessel lumen and placing a vascular aperture closure deviceinside the vessel lumen comprising the steps of: providing an introducersheath having an opening therein; providing a syringe containing fluidcommunicating with an interior of the sheath; depressing a syringeplunger to eject the fluid through the opening in the sheath as it isinserted through the tissue towards the vessel wall, the degree ofdepression being relatively small as the sheath remains within thetissue and outside the vessel; detecting a change in the depression ofthe syringe plunger to indicate greater ejection of fluid to therebyindicate that the sheath is through a tissue tract and through a vesselwall aperture into the vessel lumen; and inserting a closure memberthrough the sheath and inside the vessel to seal the aperture in thevessel wall.
 7. The method of claim 6, wherein the step of inserting theclosure member comprises the step of inserting a closure member having apatch member having a dimension at least substantially equal to adimension of the internal opening of the aperture to prevent egress offluid through the aperture.
 8. The method of claim 7, wherein the stepof detecting a change in the depression of the syringe plunger comprisesthe step of feeling the change in pressure of the syringe.
 9. The methodof claim 7, further comprising the step of withdrawing the patch membertoward the internal opening in the vessel wall to press against aninternal wall of the vessel.
 10. The method of claim 7, wherein the stepof inserting the closure member includes providing a delivery instrumentin the introducer sheath, and wherein after deployment of the patchmember from the delivery sheath the delivery instrument is furtherwithdrawn to expose clip legs of the closure member.
 11. The method ofclaim 10, further comprising the step of utilizing the syringe to ejectcool saline to the clip legs during delivery to maintain the legs in acooled martensite state.
 12. The method of claim 10, further comprisingthe step of removing the syringe and attaching another syringe to ejectcool saline to the clip legs during delivery to maintain the legs in acooled martensite state.